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Advent Of Artificial Pancreas Tech To Galvanize Fast-Growing Diabetes Market

The global diabetes management devices market is expected to exceed $11.2bn by 2020, driven largely by the rising diabetes epidemic. This, in turn, is fueling significant innovation such as next-generation, automated artificial pancreas systems and miniaturized, less-invasive wireless technologies that can continuously track and analyze glucose levels in real-time. This feature looks more closely at these and other potentially groundbreaking new technologies, as well as the competitive landscape of the two major product segments – insulin pumps and blood glucose monitors.

Diabetic Care Metabolic Commercial

Practicing What It Preaches: US FDA Device Center To Build Its Own Quality System, Become ISO 9001 Compliant

The head of the Center for Devices and Radiological Health's compliance office says it wants to be in the "tent together" with medical device manufacturers by creating a quality system for its own internal operations that will be based on the standard from the International Organization for Standardization.

Quality Control FDA Compliance

Gottlieb Wants Timely Approval Of User Fee Bill, Balanced LDT Plan

FDA Commissioner-nominee Scott Gottlieb was approved by the Senate HELP committee April 27, sending his confirmation to the full Senate. Written responses from Gottlieb to senators' questions provided in advance of the vote don't hold any big surprises, but they provide a view into priorities of the incoming official and the lawmakers, including quick user-fee reauthorization, resolving the lab-developed test oversight debate, off-label and "right-to-try" issues and post-market surveillance.

Policy Leadership Legislation

A New NEST: MDIC Leaders Discuss Relocation, National Evaluation System And More

Medical Device Innovation Consortium's CEO William Murray and VP for Technology Innovation Dawn Bardot sat down with Medtech Insight during the recent Design of Medical Devices conference in Minneapolis to discuss what their organization has been doing lately and some future focuses in the areas of regulatory science and device data collection.

Research & Development Innovation Medical Device
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Webinar: What's Ahead For IVD Regulations In The EU And US

In this hour-long webinar, Medtech Insight's Amanda Maxwell and David Filmore, and In Vivo's Ashley Yeo discuss regulatory reforms in the works for in vitro diagnostics in the EU and US.

In Vitro Diagnostics Regulation Europe

The Patient Perspective: Upcoming US FDA Device Center Studies Put Device-Users In Front Seat

A patient's point of view is paramount as the Center for Devices and Radiological Health embarks on a plan to conduct patient-perspective studies to ascertain what device-users want and value when it comes to health care. But don't call it a "survey" – "this is real research," CDRH compliance chief Robin Newman says.

FDA Medical Device Policy

Legislation Would Streamline Risk-Classification For Device Accessories

A bill introduced in the US that industry stakeholders want to be added to the "must-pass" user-fee reauthorization bill would create a tailored approach to classifying or reclassifying device accessories, following up on change made last year that requires accessories to be classified separately from parent devices. Streamlining accessory oversight has been an industry goal, particularly of health-software makers.

Digital Health Legislation

US FDA Still Waiting For Cures Money, Woodcock Says

When asked about Cures-related hiring, the FDA drug-center director says to her knowledge, no funding has been received yet.

FDA Policy

Unapproved Indications Guidance Proves Controversial

US FDA has collected more than 100 comments on a pair of draft guidance documents about manufacturer speech relating to unapproved devices or information not listed in device labeling. A document allowing manufacturers to disseminate some information not in the labeling drew fire from both sides, with patient groups worrying the change could pose a risk to the public, while trade groups saying the communication protections were still too narrow.

Advertising, Marketing & Sales Regulation

HHS Pressured By Lawmakers To Release Pandemic-Flu Plan

Two House Committee leaders are asking HHS Secretary Tom Price about the current status of an overdue pandemic influenza preparedness plan, including diagnostic advancements, that was promised last August. The lawmakers say they are worried about a US return of the H7N9 avian influenza virus, which re-emerged in China earlier this year.

In Vitro Diagnostics Infectious Diseases

FDA Warning Letter Roundup & Recap – April 25, 2017

US FDA did not release any device-related warning letters the week of April 25.

Device Warning Letters Medical Device

Feds Holding Workshop on Medical Device Cybersecurity Gaps

Following several cases highlighting medical device cybersecurity vulnerabilities and concerns from experts and lawmakers about the federal government's response, FDA is joining with Homeland Security and the National Science Foundation to hold a two-day workshop to discuss potential gaps and how to fix them.

Regulation Safety

Quality Control Explore this Topic

Latest From Quality Control

Snapshot: Device Recalls Tick Up Only 1% In 2016 Despite Midyear Surge

A count of fiscal year 2016 recalls provided by the agency shows that there were 43 high-risk class I (4%), 1,090 class II (92%) and 50 class III (4%) recalls last year, up a mere percentage point from the prior year. Device-makers had been on pace for a more modest number of corrections and removals for 2016, but a sudden mid-calendar-year spike in recalls caused the total to jump significantly.

Recalls Compliance

Medtronic StratMR Device Gets Class I Recall

Following a voluntary recall from Medtronic of its StratMR adjustable valves and shunts, US FDA has issued the highest level of recall for the devices, stating they could severely injure patients or cause death.

Recalls Safety

US FDA Device Center Pushes 'Total Product Life Cycle' Concept; 'Reorganization' Coming, Says Compliance Chief

The Center for Devices and Radiological Health is shaking up how its pre- and post-market specialists interact under a new "Total Product Life Cycle" scheme.

Life Cycle Management Quality Control

Commercial Explore this Topic

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Emerging Markets Welcome Rise Of Robots, But UK Skeptical

New research from Pricewaterhouse Coopers finds that emerging economies are more willing to embrace the use of AI and robotics in health care, compared to Western European countries. The report – "What Doctor? Why AI and Robotics Will Define New Health" – surveyed more than 11,000 people from 12 countries across Europe, the Middle East and Africa. Among these countries, the UK proved to be the biggest skeptic.

Innovation Market Access Commercial

Latest From Commercial

Stent Leaders Pull Out Of India Amidst Price Cap Storm; Opportunity For 'The Dragon'?

The storm in India over price caps on stents has not shown any signs of abating, with foreign firms seeking to pull back certain key brands and the pricing regulator resolute about maintaining market equilibrium. The slugfest also appears to have opened up the Indian market for Chinese firms, among others.

India Cardiovascular

BD, CR Bard Merger To Create Vascular Access Device Giant

Becton Dickinson has reached a definitive agreement to acquire CR Bard for $24bn. BD says Bard's product portfolio gives it a strong presence in fast-growing clinical areas and more reach outside the US while Bard expects to reach more customers by building on BD's leadership in medication management and infection prevention.

Companies Commercial

Nanjing BioPoint Shoots For 2018 Double POC Launch; Seeks $10m

A China-based IVD company, spun out of an Australian medical research institute, is seeking investors to support its plans for the 2018 launch its first two point-of-care tests for patients with infectious diseases including HIV and viral hepatitis.

In Vitro Diagnostics Financing

Device Week – April 21, 2017

On this week's Medtech Insight podcast we highlight two big M&A deals: Abbott & Alere, and Medtronic & Cardinal Health.

Commercial Deals

STAT-DX Aims To Take On Rival BioFire In Syndromic Testing

Barcelona start-up STAT-DX is gearing up to launch a new decentralized multiplex PCR system in the rapidly growing field of syndromic testing. The company, which will face larger rivals such as bioMérieux's BioFire, will unveil its new point-of-care platform at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), in Vienna from 22-25 April.

Infectious Diseases In Vitro Diagnostics

Cellnovo Targets 2018 Launch Of Insulin Micropump With Artificial Pancreas Tech

Cellnovo has signed a commercial license agreement with digital health firm TypeZero to integrate its artificial pancreas software technology into Cellnovo’s digitally connected insulin patch pump. The integrated product is expected to launch in 2018.

Deals Diabetic Care

Clinical R&D Explore this Topic

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Starts & Stops: ICS' Emblok Medtronic's Arctic Front, Abbott's Absorb, Boston Scientific's S-ICD

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions each month. Over the last month, 31 new trials started, 25 trial were completed, one trial was "reinitiated," and six trials were terminated or suspended, according to meddevicetracker.

Clinical Trials Research & Development Starts & Stops

Latest From Research & Development

Start-Up Spotlight: Amniox Medical, Bringing The Benefits Of Amniotic Tissue To Ortho And Wound Care

Amniox Medical is developing biologics products for wound-healing and orthopedic applications based on technology that takes advantage of the unique anti-inflammatory and anti-scarring properties of human amniotic membrane and umbilical cord matrix.

Regenerative Medicine Wound Healing & Tissue Repair

Edwards Gets Early Present With FDA Clearance

While Edwards Lifesciences was hoping for a 510(k) clearance later in the year, the company got the greenlight to market its new hemodynamic monitoring system, HemoSphere, in the first quarter.

Cardiovascular Cardiology

ElectroCore's gammaCore Gets US Clearance For Cluster Headaches

The de novo clearance is the first US clearance for electroCore's non-invasive vagus nerve stimulation therapy. The company will market it through headache specialists as a non-pharmacological alternative to sumatriptan for patients with cluster headaches, which afflict about 350,000 people in the US.

Neurology Innovation

Device Debuts: Tryton, Myriad Genetics, Integra Lifesciences, Acelity, And Toyota

This edition of device debuts highlights a wide variety of innovative devices introduced into commercial markets since the beginning of March, including a new stent for side-branch coronary interventions, an assay that identifies which breast-cancer patients do not need chemotherapy, a full ankle prosthesis, improvements to a negative-pressure wound therapy system, and a robotic system that helps paralyzed people learn to walk again.

Research & Development Clinical Trials

Game On For Akili's Cognitive Control Tech

A digital video game developed by Akili Interactive Labs for treating cognitive disorders has demonstrated in a pilot study its ability to improve cognitive control test scores of neurotypical children and children with sensory processing dysfunction (SPD). The company is also anticipating a market launch of the device for pediatric attention deficit hyperactivity disorder in 2018.

Digital Health Neurology

Philips' eICU Telemedicine Program Yields Cost Savings, Slows Readmissions For Emory

Five Emory University-affiliated hospitals taking part in a Philips eICU program cut total costs by $4.6m – or $1,468 per average care episode – reduced discharges to nursing homes by 6.9%, and lowered inpatient readmission rates, according to a recent audit by CMS contractors.

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